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This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program, a 6-week collaborative care intervention to help prepare individuals for repair of aortic aneurysms.
This is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the Ready for Recovery program. Ready for Recovery is a 6-week collaborative care program to prepare individuals for surgical procedures to repair an aortic aneurysm. Participants will speak with a study trainer on the phone each week and will set goals related to physical activity, a healthy diet, and inspiratory muscle training. They also will be given resources to reduce stress, treat anxiety and depression (if present), and stop smoking, and the study team will make recommendations regarding medication adjustments to reduce complications after surgery. The primary outcome is feasibility (measured by percentage of phone sessions completed). Secondary outcomes include acceptability (measured by weekly 0-10 utility ratings) and preliminary impact on functional, psychological, and health behavior outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ready for Recovery | Experimental | Participants in this arm will receive the Ready for Recovery intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ready for Recovery | Behavioral | The Ready for Recovery program is a 6-week, multicomponent, tailored, prehabilitation intervention to promote the optimization of medical and psychological status prior to surgery. Its key components include education, enhancement of beneficial health behaviors, reduction of negative psychological symptoms, and the promotion of social support. Following an initial session, the team will develop a customized prehabilitation plan for each participant. Participants will work towards goals each week and will discuss progress with their study trainer via weekly phone sessions, which will continue until the scheduled surgical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention feasibility | Percentage of intervention phone sessions completed | Weekly over 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of data collection | Proportion of assessment sessions in which outcome data is obtained from participants and the medical record | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Utility of the Ready for Recovery program |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score) | The SF-12 physical component score will be used to assess physical health-related quality of life (Range: 0-100). Higher scores indicate higher levels of physical health-related quality of life. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher M Celano, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02155 | United States |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D016879 | Salvage Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Participants will rate the utility of the Ready for Recovery program on an 11-point Likert scale (0-10), with 0 being not at all helpful and 10 being very helpful. |
| 6 weeks |
| Change in physical function (PROMIS PF-20) | Physical function will be measured using the 20-item PROMIS Physical Function Scale (PROMIS PF-20). PROMIS PF-20 scores range from 20 to 100, with higher scores indicating higher levels of physical function. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score) | The SF-12 mental component score will be used to assess mental health-related quality of life (Range: 0-100). Higher scores indicate higher levels of mental health-related quality of life. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Change in depressive symptoms (9-item Patient Health Questionnaire [PHQ-9]) | Depressive symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). The PHQ-9 ranges from 0-27, with higher scores indicating higher levels of depression. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Change in anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7]) | Anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). The GAD-7 ranges from 0-21, with higher scores indicating higher levels of anxiety | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Change in perceived stress (Perceived Stress Scale) | Perceived stress will be assessed via the Perceived Stress Scale (PSS). PSS scores range from 0-40, with higher scores indicating higher levels of perceived stress. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Change in cognition (telephonic Montreal Cognitive Assessment [t-MoCA]) | Cognition will be measured using the telphonic Montreal Cognitive Assessment (t-MoCA). t-MoCA scores range from 0 to 22, with higher scores indicating better cognition. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Change in perceived social support (Multidimensional Scale of Perceived Social Support) | Perceived social support will be measured by the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS scores range from 1-7, with higher scores indicating higher levels of perceived social support. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week) | This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |
| Changes in cigarette smoking (in number of cigarettes smoked per week) | Participants will be asked how many cigarettes they have smoked in the past week. | Baseline, post-intervention (1-5 days prior to surgery), post-operation (1-2 days before or after hospital discharge), 90 days post-discharge |